| CTRI Number |
CTRI/2024/10/075495 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Primary Dysmenorrhea on Physical Activity and Agility in Adolescent Females: A Comparative Study of Athletes and Non-Athletes |
|
Scientific Title of Study
|
Psychological effect on physical activity, agility among athletic and non-athletic females with primary dysmenorrhea: An observational cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikas Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9811162111 |
| Fax |
|
| Email |
vikassharma.smas@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Sharma |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9811162111 |
| Fax |
|
| Email |
vikassharma.smas@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Priya Panda |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8368779804 |
| Fax |
|
| Email |
priya.panda12112001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikas Sharma |
Galgotias University |
Room no: E003, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9811162111
vikassharma.smas@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
Only Delhi-based women with primary dysmenorrhea are the subjects of this study,
The players which play outdoor games (such as volleyball, football, cricket) of
numerous sports complexes, colleges sports clubs, etc. |
|
| ExclusionCriteria |
| Details |
Pregnancy
Suffering from secondary dysmenorrhea,
Possessing pelvic pathology
Acetaminophen, naproxen, aspirin, ibuprofen, or any other nonsteroidal antiinflammatory drug is known to the doctor to cause an allergy, an uncommon reaction,
or a serious adverse event in the patient (NSAID).
Those who do physical activity less than 3 days in a wee |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DASS (Depression Anxiety Stress Scale) |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Verbal Multidimensional Scoring System for assessment of dysmenorrhea severity |
4 week |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary dysmenorrhea is a prevalent gynaecological disorder characterised by unpleasant
menstrual cramps in the absence of an underlying organic illness(1). It affects a substantial
number of women globally, with prevalence rates ranging from 45% to 95% among menstrual
women. The symptoms of primary dysmenorrhea may be severe, resulting to decreased quality
of life, poor daily functioning, and psychological discomfort(2). While the physiological
features of primary dysmenorrhea have been thoroughly investigated, the effect of physical
exercise and agility on the psychological well-being of persons with this illness remains
understudied(3).
Dysmenorrhea, or unpleasant menstrual cramps, is a prevalent gynaecological disorder that
affects a considerable proportion of menstruation women. Primary dysmenorrhea and
secondary dysmenorrhea are its two classifications(4). Primary dysmenorrhea refers to
menstruation discomfort that occurs without any underlying organic pathology, while
secondary dysmenorrhea is caused by a diagnosable medical illness, such as endometriosis or
uterine fibroids(5).
Primary dysmenorrhea is characterised by the contraction of the uterine muscles, notably the
myometrium, which is responsible for the ejection of the endometrium during menstruation.
These contractions are mediated by prostaglandins, which are hormone-like molecules secreted
by the uterine lining(6). Increased amounts of prostaglandins cause uterine muscular
contractions that are excessive, resulting in discomfort and cramping. Several variables have
been suggested in the aetiology of primary dysmenorrhea, while the precise reason remains
unknown. Unbalanced levels of prostaglandin are one of the contributing reasons. Women with
primary dysmenorrhea often have elevated levels of prostaglandins, notably prostaglandin F2,
which is linked to more severe and protracted uterine contractions. A heightened sensitivity of
the uterine muscle to prostaglandins may also contribute to the development of primary
dysmenorrhea(7). This heightened sensitivity may result in increased menstrual contractions
and more intense discomfort.
Furthermore, lifestyle and behavioural variables might impact the severity of primary
dysmenorrhea symptoms. Stress, lack of physical exercise, poor food habits, and smoking have
been connected with greater pain and discomfort during menstruation(8). The physiological
processes driving dysmenorrhea may be exacerbated by these conditions, resulting in more
severe symptoms(9). |